Strategic Regulatory Intelligence: identification, access and integration for critical components of information needed to have successful new medical products reach patients quickly.
Regulatory Pathfinding: identification of novel regulatory pathways for biomarker-driven therapeutic and diagnostic product development.
The path to precision medicine medical product regulatory approval
The regulatory approval of therapeutic and diagnostic products is a science-driven process. Complex and nuanced scientific discussions with regulatory agencies for precision medicine products take time. These discussions also need to be strategically integrated with prescriptive pathways (i.e., NDAs, IDEs) for regulatory approval. How early should sharing of scientific ideas, concepts and data with regulatory agencies start? How well do prescriptive pathways capture the regulatory context of novel precision medicine products?
Regulatory Pathfinders is a consultancy for therapeutics and in vitro diagnostics. Its focus is on regulatory strategy design and development for companion diagnostics, combination products, and other medical products requiring complex and/or novel regulatory pathways. This focus is drawn from broad experience in the application and regulatory acceptance of patient selection biomarkers, companion diagnostics, alternative endpoints and surrogate biomarkers for clinical trials.